NAVI AMAZON PROPOL- sodium monofluorophosphate silicon dioxide paste
EQMAXON Corp.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENT

Active Ingredients: Silicon Dioxide 16%, Sodium Monofluorophosphate 0.19%

PURPOSE

Purpose: Anticavity

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 6 years old

INDICATIONS & USAGE

- Supervise children as necessary until being capable of using without supervision

- Instruct children under 6 years old in good brushing and rinsing habits

WARNINGS

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away

INACTIVE INGREDIENT

Inactive Ingredients: Propolis Extracts, Silica, Chitosan, Sorbitol Solution, Licorice Extracts, Xylitol

DOSAGE & ADMINISTRATION

- Brush teeth twice daily or after each meal as directed by a dentist or doctor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

NAVI AMAZON PROPOL
sodium monofluorophosphate silicon dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55526-0001
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.228 g in 120 g

Ingredient Name	Strength
Inactive Ingredients
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)	3.6 g in 120 g
GLYCERIN (UNII: PDC6A3C0OX)	6 g in 120 g
ERYTHRITOL (UNII: RA96B954X6)	0.12 g in 120 g
XYLITOL (UNII: VCQ006KQ1E)	0.24 g in 120 g
STEVIOL (UNII: 4741LYX6RT)	0.24 g in 120 g
CHITOSAN OLIGOSACCHARIDE (UNII: 23R93M6Y64)	0.12 g in 120 g
LICORICE (UNII: 61ZBX54883)	0.12 g in 120 g
GREEN TEA LEAF (UNII: W2ZU1RY8B0)	0.12 g in 120 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55526-0001-1	120 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2013	11/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	01/01/2013	11/01/2019

Labeler - EQMAXON Corp. (557821534)

Registrant - EQMAXON Corp. (557821534)

Name	Address	ID/FEI	Business Operations
Establishment
EQMAXON Corp.		557821534	manufacture(55526-0001)

Revised: 12/2019

Document Id: 7491eec7-4567-4d4f-ade8-659e0e094f85

Set id: 622d4f43-6a97-4990-a239-0ef187d9b365

Version: 2

Effective Time: 20191226

EQMAXON Corp.